OFICE, SL is a Pharmacist laboratory in quality control authorized by Spanish Agency for Medicines and Health Products applied:
– Physical-chemical products for human use and veterinary use.
– Microbiological analysis of non-sterile medicins for human and veterinary use.
– Physical-chemical medicines for human use in clinical trials.
– Microbiological analysis of non-sterile medicines for human use in research and clinical trials.
OFICE, SL performs a wide range of analysis.
PHYSICOCHEMICAL ON QUALITY CONTROL RAW MATERIALS AND FINISHED PRODUCT.
* Quantification and characterization of active principle
* Characterization of the impurity profile
* Identification and characterization of impurities
* Residuals Solvents determination.
* Potentiometric determination of PH
* Loss on drying
* Index of refraction
* Optical Rotation
* Acid index.
* Saponification index.
* Oxidizing Substances
* Heavy metals test
* Testing limits
* Insoluble ash
MICROBIOLOGICAL QUALITY CONTROL OF RAW MATERIALS AND FINISHED PRODUCT..
* Tests for counting microorganisms in non-sterile products.
* Tests for specific microorganisms count in non-sterile.
* Bacterial Endotoxin.
* Microbiological control of pharmaceutical products herbal.
* Control of production and purified water.
CONTROL ROOM CLASSIFIED
* Control surfaces.
* Control of environments.
* Stability studies at temperature and humidity controlled according to ICH under long-term, intermediate and accelerated conditions.
* Studies of stability in use.
For the realization thereof provides the following techniques:
* Gas Chromatography-HeadSpace.
* Liquid Chromatography.
* Atomic Absorption Spectrophotometry.
* Infrared spectrophotometry.
* UV-Visible spectrophotometry.
* Thin layer chromatography .
* Immunoassay (ELISA)